There used to be a time when one could discern a fake cosmetic product from an authentic one by just examining the package. Certain external characteristics—or flaws—like a misspelled word or a flimsy material would give it away. Now, printing and imaging technology has evolved and become so inexpensive that counterfeiters can easily obtain it to create packaging that fools even the savviest consumer. Third-party sellers online like Amazon, Jet.com and other smaller e-retailers have made it...

On March 25, 2019 the Prescription Drug Security Alliance (PDSA) published the first of three white papers that describe their proposal for establishing a new, non-profit governance organization that would be responsible for ensuring interoperability of the Drug Supply Chain Security Act (DSCSA) solutions. This first paper is called “A Proposal: Governance for DSCSA Phase II Interoperability”. In addition, PDSA also published another paper called “An Overview: PDSA Vision for Phase II...

Systech has been conducting educational webinars on important market issues for many years now. Much of this has centered on getting our customers the information they need to meet major pharmaceutical serialization requirement mandates in the United States (DSCSA) and the European Union (FMD). Now, with these mandates “live”, customers are looking at value beyond compliance in their serialization environments and investments.

No country is immune from the ravages of drug addiction, abuse and overdose. Last month, news broke of the rising number of deaths in Northern Ireland and the entire UK in general due to counterfeit Xanax which is indicative of this global epidemic. It doesn’t matter if a drug is legalized, prescription-only or not even for sale in a country. If there is a demand for it, it will be available by some channel. No software company, Systech included, is going to stop counterfeiters from...

Bootlegging alcohol didn’t get left behind in the Prohibition Era. In fact, according to a 2014 report by the World Health Organization, unregulated alcohol makes up 25% of all consumption worldwide. But what are the implications of fake alcohol? Why should everyone from consumers to manufacturers to government entities care? Let’s take a look at the facts.

Drug repackagers face unique challenges under the Drug Quality and Security Act (DQSA), driven by their distinctive position in the pharmaceutical supply chain. One major US drug repackager needed a solution with a wide breadth of features and comprehensive configurability to get in compliance with DQSA so they reached out to Systech for assistance.

First and foremost, a successful serialization program involves far more than just placing serial numbers on packaging -- regardless of the market. However, pharmaceutical companies that distribute in more than one country face significant regulatory compliance complexity, with each additional market adding another layer of challenges. Regulations differ between markets, and can change often enough meaning regulatory professionals must be prepared to adjust processes, procedures and filings...

In late August, the China National Drug Administration (CNDA) posted three new draft guidance documents detailing a proposed National Drug Regulatory Information Standard and Traceability System. Chinese versions of the drafts are available now but the agency is requesting feedback from stakeholders and the public to be submitted by September 20, 2018. Final versions are likely to appear soon after that.